GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. K073462: The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash 3000/4000/5000 patient monitor is designed as a bedside, portable, and intra-hospital transport monitor that can operate in all professional medical facilities including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, free-standing surgical centers, and other alternate care facilities. Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, inoninvasive blood pressure, heart rate, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, bi-spectral index, impedance cardiography, oxygen, and anesthetic agents as summarized in the operators manual. The Dash 3000/4000/5000 patient monitor is also intended to provide physiologic data over the UNITY NETWORK indirectly to clinical information systems (via our Enterprise Gateway) and allow the user to access hospital data at the point-of-care. The information can be displayed, trended, stored, and printed. The Dash 3000/4000/5000 patient monitor was developed to interface with nonproprietary third party peripheral devices that support serial data outputs. K992929: The Dash 3000 Patient Monitoring System is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash is designed as a bedside, portable, and transport monitor that can operate in all professional medical facilities and medical transport modes including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, freestanding surgical centers, and other alternate care facilities, intra-hospital patient transport, inter-hospital patient transport via ground vehicles (i.e. ambulance, etc.) and fixed and rotary winged aircraft, and prehospital emergency response. Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, and carbon dioxide as summarized in the operators manual. The Dash 3000 Patient Monitoring System is also intended to provide physiologic data over the Unity network to clinical information systems and allow the user to access hospital data at the point-of-care. This information can be displayed, trended, stored, and printed.

Detalles del retiro

Fabricante

GE Healthcare, LLC

Distribuidor

Worldwide Distribution: US (nationwide) including DC and PR except SD, VT and WY; and Internationally to: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, EGYPT, GERMANY, UNITED KINGDOM, IRELAND, IRAQ, ISRAEL, JAMAICA, JAPAN, JORDAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MARITIUS, MALDOVA, NEW ZEALAND, NIGERIA, PAKISTAN, PANAMA, PARAGUAY, PERU, POLAND, QATAR, RUSSIA, SLOVAKIA, SOUTH AFRICA, SWEDEN, SWITZERLAND, TUNISIA, UNITED ARAB EMIRATES, VENEZUELA, CHILE, CANADA, and BERMUDA.

Lote

Serial Number F1DJ2018G H9DJ0236G E1DJ0384G SBG06398779GA A3DJ4203G J2DJ8331G SBG06182479GA SBG06192680GA F2DJ5762G DSH04532005GA G1DJ2217G E2DJ3710G M3EH8966GR L0DJ5294G SBG05463469GA SBG06264541GA M2DJ2447G J3EH5175G L2DJ1220G B0DJ1561G SD007293609GA L2DJ1263G C1DJ8662G A4EH1258G F0DJ3308G SBG06046629GA SD007262789GA AAB04254355GA SD008429849GA B2DJ1915G DSH05293139GA SD008138223GA H9DJ0155GR SD007251995GA H1DJ3351G SBG06046550GA F2DJ5089G DSH05185989GA H2DJ7244G F1DJ1599G M1DJ7820G DSH05318073GA M2DJ3629G L1DJ6712GR D2DJ2937GR K0DJ5004GR SD007335572GA AAB04231070GA H2DJ7075G K1DJ5436G K1DJ4937G F1DJ1095G B0DJ1414G E2DJ3955G E2DJ4138GR F1DJ1219G A2DJ9815G SBG06451891GA A3DJ4322G SBG05514986GA DSH05318052GA C3DJ7072G H2DJ7154G G2DJ6587GR DSH05292993GA DSH04470444GA M2DJ2896G H9DJ0359G E1DJ0785G DSH05293010GA F0DJ3187G SBG06264685GA D0DJ2288G M9DJ1149G A2DJ9164G G0DJ3490G AAB04356778GA F0DJ3109GR SD007462511GA DSH05083862GA B1DJ7749G SD007451806GA SD010387765GA B2DJ9976G E1DJ1008G C1DJ8498G DSH05043084GA SBG05525493GA DSH05032811GA SD010117163GA SD009316807GA SBG06336410GA M2DJ2785G M2DJ1981G B2DJ1162GR SD007462383GA B4EH4615G DSH05358956GA G1DJ2480G K2DJ9527G DSH05328251GA SD007303935GA SD009389115GA E3DJ8843GR L3EH8132G AAB04190508GA D3DJ8386G SD008526318GA SD008294211GA E1DJ0742G K0DJ4668G L3EH8063G F1DJ1089GR SD007397737GA E3DJ8752G C1DJ8754G DSH05307981GA E3DJ9275G L1DJ6819G F0DJ3079G B3DJ5494G B4EH4576G SD008377628GA E2DJ3754G DSH05185950GA SD008515789GA D2DJ3339GR G2DJ6198G E1DJ0656G SBG06451791GA J0DJ4421G DSH05063506GA DSH05328266GA E2DJ3688G DSH05022478GA L2DJ1506G G2DJ6199G C2DJ1967G D0DJ2360G L1DJ6959G J3EH5899G H1DJ3337G SHQ12167194SA J1DJ4547G D2DJ3227G C1DJ8552G E2DJ3637G AAB04377453GA AAB04264700GA J2DJ8391G SHQ12402047SA SD010251247GA L3EH7800GR E1DJ0720G F0DJ2863G AAB04377323GA L0DJ5701G H2DJ7092G F2DJ6031G M2DJ3100GR SD007252034GA AAB04139260GA AAB04160036GA AAB04160038GA AAB04160040GA AAB04160042GA AAB04160044GA AAB04160048GA AAB04160048GR AAB04160049GA AAB04160079GA AAB04160080GA AAB04160082GA AAB04180103GA AAB04180117GA AAB04180121GA AAB04180123GA AAB04180124GA AAB04180126GA AAB04180127GA AAB04180128GA AAB04180129GA AAB04180130GA AAB04180137GA AAB04180138GA AAB04180141GA AAB04180165GA AAB04180166GA AAB04180167GA AAB04180168GA AAB04180169GA AAB04180184GR AAB04180186GA AAB04180188GA AAB04180190GA AAB04180191GA AAB04180192GA AAB04180211GA AAB04180212GA AAB04180213GA AAB04180218GA AAB04180218GR AAB04180219GA AAB04180250GA AAB04180251GR AAB04180259GA AAB04180260GA AAB04180261GR AAB04180262GA AAB04180278GR AAB04180283GA AAB04180284GA AAB04180285GA AAB04190302GA AAB04190307GA AAB04190312GA AAB04190313GA AAB04190314GA AAB04190316GA AAB04190318GA AAB04190319GR AAB04190322GA AAB04190325GA AAB04190333GA AAB04190335GA AAB04190337GA AAB04190339GA AAB04190344GA AAB041903479GA AAB04190352GA AAB04190353GA AAB04190354GA AAB04190376GA AAB04190378GA AAB04190379GA AAB04190383GA AAB04190384GA AAB04190388GA AAB04190389GA AAB04190394GA AAB04190398GA AAB04190402GA AAB04190436GA AAB04190437GA AAB04190438GA AAB04190439GA AAB04190454GA AAB04190467GA AAB04190468GA AAB04190473GA AAB04190482GA AAB04190483GA AAB04190484GA AAB04190485GA AAB04190486GA AAB04190487GA AAB04190488GA AAB04190495GA AAB04190496GA AAB04190497GA AAB04190498GA AAB04190500GA AAB04190501GA AAB04190501GR AAB04190504GA AAB04190504GR AAB04190505GA AAB04190506GA AAB04190509GA AAB04190510GA AAB04190512GR AAB04190515GA AAB04190516GA AAB04190517GA AAB04190527GA AAB04190528GA AAB04190529GA AAB04190530GA AAB04190531GA AAB04190539GA AAB04190541GA AAB04190545GA AAB04190546GA AAB04190548GA AAB04190549GA AAB04190551GA AAB04190552GA AAB04190553GA AAB04190555GA AAB04190570GA AAB04190571GA AAB04

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States